K181522 is an FDA 510(k) clearance for the PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope. This device is classified as a Duodenoscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FDT).
Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on July 9, 2018, 28 days after receiving the submission on June 11, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K181522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2018 |
| Decision Date | July 09, 2018 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDT — Duodenoscope And Accessories, Flexible/rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |